Simvastatin Alter 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Simvastatina Alter 10 mg film-coated tablets EFG

Simvastatina Alter 20 mg film-coated tablets EFG

Simvastatina Alter 40 mg film-coated tablets EFG

Simvastatin

Read all of this leaflet carefully before you start taking this medicine , because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Simvastatina Alter is and what it is used for
2. What you need to know before taking Simvastatina Alter
3. How to take Simvastatina Alter
4. Possible side effects
5. How to store Simvastatina Alter
6. Contents of the pack and other information

1. What Simvastina Alter is and what it is used for

Simvastatina Alter contains the active substance simvastatin. Simvastatina Alter is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat called triglycerides circulating in the blood. In addition, Simvastatina Alter increases levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a class of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow may cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects them from heart disease.

Triglycerides are another type of fat in your blood that may increase the risk of heart disease.

While taking this medicine, you must follow a cholesterol-lowering diet.

Simvastatina Alter is used, together with a cholesterol-lowering diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fatty substances in the blood (mixed hyperlipidemia).
• a hereditary condition (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel disease). Simvastatina Alter may prolong your life by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol levels, and discuss your target goals with your doctor.

2. What you need to know before taking Simvastatina Alter

Do not take Simvastatina Alter

• If you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in section 6).

• If you currently have liver problems.

• If you are pregnant or breastfeeding.

• If you are taking medicines containing one or more of the following active substances:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections).

• Erythromycin, clarithromycin, or telithromycin (used to treat infections).

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections).

• Boceprevir or telaprevir (used to treat hepatitis C virus infection).

• Nefazodone (used to treat depression).

• Cobicistat.

• Gemfibrozil (used to lower cholesterol).

• Cyclosporine (used in organ transplant patients).

• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and Simvastatina Alter may cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat rare, severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medicine is included in the list above.

Warnings and precautions

Talk to your doctor or pharmacist before starting Simvastatina Alter.

Inform your doctor:

• About all your medical conditions, including allergies.

• If you consume large amounts of alcohol.

• If you have ever had liver disease. Simvastatin may not be suitable for you.

• If you are scheduled for surgery. You may need to stop taking simvastatin tablets for a short period of time.

• If you are of Asian origin, as you may require a different dose.

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking simvastatin and also if you develop any symptoms of liver problems while taking simvastatin. This is to check how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor liver function after you start treatment with simvastatin.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk is higher if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Inform your doctor if you have a severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of simvastatin, especially the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk to your doctor if any of the following apply to you:

• You consume large amounts of alcohol.
• You have kidney problems.
• You have thyroid problems.
• You are 65 years of age or older.
• You are female.
• You have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates.
• You or a close family member have an inherited muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

The efficacy and safety of simvastatin treatment have been studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year prior (see section 3. How to take Simvastatina Alter). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Taking Simvastatina Alter with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines containing any of the following active substances. Taking simvastatin with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above “Do not take Simvastatina Alter”).

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with Simvastatina Alter. Using Simvastatina Alter with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

• Cyclosporine (often used in transplant patients).

• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• Medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).

• Fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol).

• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS).

• Hepatitis C antivirals such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection).

• Nefazodone (used to treat depression).

• Medicines containing the active substance cobicistat.

• Amiodarone (used to treat irregular heart rhythm).

• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).

• Lomitapide (used to treat rare, severe genetic cholesterol disorders).

• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be increased when this medicine is taken during simvastatin treatment. Your doctor may decide that you should temporarily stop taking Simvastatina Alter.

• Colchicine (used to treat gout).

• Ticagrelor (an antiplatelet medicine).

• Ribociclib (used to treat breast cancer).

• Palbociclib (used to treat breast cancer).

As well as the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• Medicines with an active substance to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants).
• Fenofibrate (also used to lower cholesterol).
• Niacin (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).

You should also inform any doctor prescribing you a new medicine that you are taking simvastatin.

Simvastatina Alter with food, drinks, and alcohol

Grapefruit juice contains one or more components that alter how the body processes certain medicines, including simvastatin. Consumption of grapefruit juice should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Simvastatina Alter if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking Simvastatina Alter, stop taking it immediately and inform your doctor. Do not take Simvastatina Alter if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Simvastatina Alter is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Simvastatina Alter.

Simvastatina Alter contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Simvastatina Alter

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment, and your individual risk situation.

Always follow exactly the instructions for use of this medicine provided by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting to take this medicine, you must be following a cholesterol-lowering diet.

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once daily by oral administration.

Adults:

The usual starting dose is 10 mg, 20 mg, or, in some cases, 40 mg per day. After at least 4 weeks, your doctor may adjust your dose up to a maximum of 80 mg per day. Do not take more than 80 mg per day.

Your doctor may prescribe a lower dose, especially if you are taking certain medicines mentioned above or if you have certain kidney disorders.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease-related problems who have not reached their cholesterol target with lower doses.

Use in children and adolescents

In children and adolescents aged 10 to 17 years, the recommended starting daily dose is 10 mg, taken at night. The recommended maximum daily dose is 40 mg.

Method of administration:

Take simvastatin at night. You may take it with or without food. Continue taking simvastatin tablets until your doctor tells you to stop.

If your doctor has prescribed simvastatin together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take the simvastatin tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Simvastatina Alter

Do not take a double dose to make up for missed doses. On the following day, take your usual amount of simvastatin at the usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you stop treatment with Simvastatina Alter

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following terms are used to describe how often the adverse effects have been reported:

• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• Frequency not known (cannot be estimated from the available data).

If any of the serious adverse effects listed below occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

The following serious adverse effects have been reported as rare:

• Muscle pain, tenderness to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity (allergic) reactions, including:
  • Swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema)
  • Severe muscle pain, usually in the shoulders and hips
  • Skin rash with muscle weakness in the limbs and neck
  • Joint pain or inflammation (polymyalgia rheumatica)
  • Inflammation of blood vessels (vasculitis)
  • Unusual bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flushes
  • Difficulty breathing (dyspnea) and general malaise
  • Pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells)
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark-colored urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare)
• Inflammation of the pancreas, often with severe abdominal pain.

The following serious adverse effects have been reported as very rare:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction).
• Skin rash, which may also involve mouth ulcers (drug-induced lichenoid eruptions)
• Muscle rupture
• Gynecomastia (enlargement of breast tissue in men)

The following adverse effects have also been reported rarely:

• Low red blood cell count (anemia)
• Numbness or weakness in arms and legs
• Headache, tingling sensation, dizziness
• Blurred vision and visual disturbances
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting)
• Skin rash, itching, hair loss
• Weakness
• Sleep disorders (very rare)
• Memory impairment (very rare), memory loss, confusion.

The following adverse effects have also been reported, but based on available information, their frequency cannot be estimated (frequency not known):

• Erectile dysfunction
• Depression
• Lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon problems, sometimes complicated by tendon rupture
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional possible adverse effects reported with some statins:

• Sleep disorders, including nightmares
• Sexual dysfunction
• Diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Persistent muscle pain, tenderness, or weakness, which may not resolve after stopping treatment with simvastatin (frequency not known).

Additional tests

In some blood tests, increases in liver function markers (transaminases) and in a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Alter

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Alter

• The active substance is simvastatin. Each tablet contains 10 mg, 20 mg or 40 mg of simvastatin.

The other components are: butylhydroxyanisole (E320), ascorbic acid, citric acid, microcrystalline cellulose, pregelatinized corn starch, lactose, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin. See section 2 Simvastatin Alter contains lactose.

Appearance of the product and contents of the pack

Simvastatin Alter 10 mg is presented as white, film-coated, biconvex tablets. It is available in packs of 28 tablets.

Simvastatin Alter 20 mg is presented as white, film-coated, biconvex tablets. It is available in packs of 28 tablets.

Simvastatin Alter 40 mg is presented as white, film-coated, biconvex tablets. It is available in packs of 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Date of the most recent review of this leaflet: March 2026

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/